1. Roles and responsibilities
Membership of the PCWP and HCPWP implies a commitment from its members, through their appointed representatives, to participate actively in the work of the working party, which includes:
Identify relevant topics for information, discussion and reflection.
Exchange views and positions from organisations, scientific committees and EMA on topics addressed by the working party.
Participate in meetings and written consultations of non-confidential nature.
Propose recommendations to EMA, scientific committees and organisations on topics addressed by the working party.
Inform their organisations and scientific committees about the activities of the working party.
Agree on the mandate, work plan and any governance-related documents of the working party. The working party shall have two Chairpersons (referred to as Co-Chairs, hereafter). One Co-Chair (also referred to as the EMA Co-Chair) will be a representative of the EMA secretariat and will be nominated by a Decision of the Executive Director. The other co-chair (also referred to as the HCPWP/PCWP Co-Chair) will be elected amongst working party members, following the procedure described in point 4. The Co-chairs shall in particular:
Plan the work of the working party together with the EMA secretariat.
Monitor, together with the EMA secretariat, that the rules of procedure are respected.
Aim to achieve consensus on issues discussed by the working party and in exceptional cases, decide if a vote is necessary.
Co-ordinate together with the EMA secretariat the work of this working party with that of other relevant working parties of the Agency…